MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-07-01 for ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 9560757 manufactured by Warsaw Orthopedic, Inc..
[2118018]
It was reported that the patient suffered burns on the back from the radiance illumination kit getting extremely hot at the connection point to the light cable of the 300 watt light source.
Patient Sequence No: 1, Text Type: D, B5
[9202211]
(b)(4). Device was not returned to the manufacturer for evaluation. We are unable to determine the cause of the event. A review of device history records is not possible at this time without additional device information.
Patient Sequence No: 1, Text Type: N, H10
[10846582]
.
Patient Sequence No: 1, Text Type: N, H10
[34903341]
.
Patient Sequence No: 1, Text Type: N, H10
[34903342]
It was reported in the patient's medical records that the patient underwent a procedure for l4-5, l5-s1 tlif. After placing the interbody cages and withdrawing the retractors, it was noticed that the patient had burns in multiple areas where it had touched the skin at the connection point. The light source was immediately removed. After implant of the posterior hardware the incision was closed and the burns were treated. Multiple linear burns were noted. The burns were irrigated and any skin over the top was debrided. The wounds were then dressed with antibiotic ointment, and then xeroform and a sterile dressing was placed over the burn areas. Post-op the patient was treated by a plastic surgeon for scar revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2011-00845 |
| MDR Report Key | 2147664 |
| Report Source | 05,07 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-06-01 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2014-03-28 |
| Device Manufacturer Date | 2010-03-31 |
| Date Added to Maude | 2011-07-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 9560757 |
| Lot Number | 0087041W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW TN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-01 |